Ketogenic Diet Variations for Type 2 Diabetes and Obesity

(KETO-IM Trial)

Overseen By Paulina Blanco Cervantes, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, Dialysis, Familial hypercholesterolemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets affect individuals at risk for or diagnosed with type 2 diabetes. It compares a ketogenic diet with canola oil (Keto-CAN), a traditional keto diet with butter and coconut oil (Keto-SAT), and a low-fat diet (LFD) to determine which best improves heart health and reduces inflammation. Participants will randomly follow one of these diets for up to six months. Individuals who are overweight or have a blood sugar level (HbA1C) of 5.7% or higher may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how dietary changes can impact diabetes management and overall health.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketogenic diets, like those in this trial, are generally well-tolerated by many people. The KETO-Can diet, a keto diet with added canola oil, lowered fasting blood sugar and improved overall metabolic health. Participants did not report serious side effects, indicating its safety for those with type 2 diabetes.

The KETO-Sat diet, which includes more saturated fats from butter and coconut oil, helped with weight loss and better blood sugar control. However, some participants experienced a decrease in muscle mass, though this varied. Overall, the keto diet is often safe, but individual experiences can differ.

Both diets show promise for improving health, but monitoring the body's reactions is important. Always consult healthcare providers before making dietary changes, especially when participating in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore different dietary approaches to managing type 2 diabetes and obesity. The Keto-Can treatment is unique because it enhances the ketogenic diet with canola oil, which is rich in monounsaturated and omega-3 fatty acids, potentially offering heart health benefits. On the other hand, Keto-Sat offers a twist by incorporating butter and coconut oil, both high in saturated fats, which could influence metabolism differently. Lastly, the low-fat diet (LFD) uses whole grains like pasta, brown rice, and oatmeal, focusing on reducing overall fat intake. These variations aim to uncover how different fats and dietary compositions impact weight loss and blood sugar control, offering new insights beyond standard low-carb or low-fat diets.

What evidence suggests that this trial's dietary treatments could be effective for type 2 diabetes and obesity?

Research has shown that ketogenic diets can help manage type 2 diabetes and obesity. Studies have found that these diets lead to more weight loss and better blood sugar control compared to low-fat diets. In this trial, participants will join different diet groups. The Keto-CAN approach, which includes healthy fats like canola oil, has been linked to improved blood sugar levels and cholesterol. Meanwhile, the Keto-SAT diet, high in saturated fats, also aids in weight and blood sugar management but may affect cholesterol differently. Overall, both types of ketogenic diets appear beneficial for diabetes and obesity, but the type of fat consumed might alter specific health outcomes. ^{5 6 7 8 9}

Who Is on the Research Team?

Catherine Chan, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults with obesity or overweight and HbA1C levels at or above 5.7%, indicating high blood sugar, which can be a sign of prediabetes or diabetes. It's not suitable for individuals with certain cholesterol or triglyceride disorders, those undergoing menopause, on dialysis, transitioning transgender individuals, pregnant women, or anyone whose diet wouldn't allow them to follow the study's nutritional guidelines.

Inclusion Criteria

You are overweight or obese and have high HbA1C levels.

Exclusion Criteria

I have a family history of high cholesterol or high triglycerides.

I am on dialysis or advised to eat a low-protein diet due to kidney function.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three dietary treatments (KETO-Can, KETO-Sat, or LFD) and receive nutrition counseling for 6 months.

6 months

Monthly visits for dietary assessment and counseling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Keto-CAN
• Keto-SAT
• LFD

Trial Overview The study is testing three diets: a ketogenic diet supplemented with saturated fat (Keto-SAT), a ketogenic diet supplemented with canola oil (Keto-CAN), and a low-fat diet (LFD). Participants will be randomly assigned to one of these diets to see how they affect heart disease risk factors like cholesterol and blood sugar levels as well as inflammation and immune function over periods of 3 and 6 months.

How Is the Trial Designed?

Group I: KETO-Sat Experimental Treatment 1 Intervention

KETO diet supplemented with butter and coconut oil (high in SFA).

Group II: KETO-Can Experimental Treatment 1 Intervention

KETO diet supplemented with Canola oil (high in MUFA and omega-3 FA).

Group III: Low fat diet (LFD) Active Control 1 Intervention

Low fat diet supplemented with whole grain foods (pasta or brown rice) and oatmeal.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A 4-year-old girl with a rare FBXL4 gene mutation and severe lactic acidosis was successfully treated with a ketogenic diet (KD) after standard treatments failed, highlighting the KD's potential in managing mitochondrial disorders.

This case represents the first documented use of parenteral KD to effectively reduce lactic acidosis in a patient with mitochondrial depletion syndrome, suggesting a promising nonpharmacological intervention for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. İnci, A., Aktaş, E., Cengiz Ergin, FB., et al.[2022]

In a study involving 11 healthy, normal-weight participants, a high-fat ketogenic diet (KD) did not improve cognitive function, mood, or sleep quality compared to a high-carbohydrate, low-fat diet over a 3-week period.

Despite achieving nutritional ketosis, the KD showed no significant effects on tasks measuring vigilance, memory, or executive function, indicating that this diet may not enhance cognitive performance in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial. Iacovides, S., Goble, D., Paterson, B., et al.[2023]

In a 16-week study involving 28 overweight participants with type 2 diabetes, the low-carbohydrate, ketogenic diet (LCKD) led to a significant 16% reduction in hemoglobin A1c levels, indicating improved glycemic control.

The diet also allowed for the discontinuation or reduction of diabetes medications in 17 out of 21 participants who completed the study, highlighting the need for close medical supervision when implementing such dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Yancy, WS., Foy, M., Chalecki, AM., et al.[2020]

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

Long-term consumption of a ketogenic diet in rats led to significant weight loss, decreased blood sugar levels, and increased blood ketones, indicating effective metabolic changes associated with this diet.

However, the ketogenic diet also resulted in metabolic acidosis and anemia, as evidenced by lower blood pH and reduced levels of erythrocytes, hemoglobin, and hematocrit, alongside a decrease in antioxidant enzyme superoxide dismutase levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Ketogenic Diet Induces Metabolic Acidosis, Anemia, and Oxidative Stress in Healthy Wistar Rats. Arsyad, A., Idris, I., Rasyid, AA., et al.[2022]

The ketogenic diet (KD) has shown beneficial effects in managing diabetes, obesity, and other endocrine disorders, including improved glycemic control and significant weight loss, based on a review of its clinical applications.

KD is also associated with positive outcomes in cardiac health and respiratory function, and a vegetarian variant has been developed to accommodate specific dietary preferences, highlighting its versatility as a therapeutic diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet in endocrine disorders: Current perspectives. Gupta, L., Khandelwal, D., Kalra, S., et al.[2019]

A polyunsaturated fat-enriched ketogenic diet (POLY KD) led to higher levels of ketosis and improved insulin sensitivity in healthy adults compared to a saturated fat-enriched ketogenic diet (SAT KD) over a 5-day period.

The POLY KD did not negatively impact cholesterol levels, unlike the SAT KD, suggesting that the POLY KD may be a safer and more effective option for long-term use in managing conditions like epilepsy and metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential metabolic effects of saturated versus polyunsaturated fats in ketogenic diets. Fuehrlein, BS., Rutenberg, MS., Silver, JN., et al.[2022]

Ketogenic diets, which consist of over 70% fat and very low carbohydrates, may be more effective than low-fat diets for treating obesity and diabetes, showing potential benefits in reducing blood glucose and insulin levels.

A well-formulated ketogenic diet appears to be safe for the general public and could be considered a first-line treatment for obesity and diabetes, although more high-quality clinical trials are needed to explore its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. Ludwig, DS.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8397683/

Efficacy of Ketogenic Diets on Type 2 Diabetes: a Systematic ... In aggregate, KD seem to have positive effects in T2D patients and persist in long-term trials, as illustrated in Fig. 1. However, the main ...

2. mdpi.com mdpi.com/2072-6643/16/23/4218

Effects of a 12 Week Ketogenic Diet Intervention on Obese ... Recent findings indicate that the KD leads to greater reductions in body mass, fasting blood glucose, HBA1c1c, and TG, as well as an increase in HDL-C, compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004784

Effectiveness of low-carbohydrate diets on type 2 diabetes Growing evidence, including randomized trials and meta-analyses, supports the efficacy of low-carbohydrate diets in type 2 diabetes management, showing ...

4. diabetesjournals.org diabetesjournals.org/care/article/37/11/2909/29068/A-Very-Low-Carbohydrate-Low-Saturated-Fat-Diet-for

A Very Low-Carbohydrate, Low–Saturated Fat Diet for Type 2 ... This study demonstrates that both energy-reduced LC and HC diets with low–saturated fat content produce substantial improvements in glycemic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11945412/

Ketogenic Diets for Body Weight Loss - PubMed Central - NIH A 2023 randomised controlled trial (RCT) showed that a hypocaloric ketogenic diet was effective in reducing daily glycaemia compared to a low-fat diet, ...

6. clinicaltrial.be clinicaltrial.be/en/details/188377?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Metabolic and Inflammatory Outcomes of the Ketogenic Diet... The purpose of our study is to investigate the health beneficial effects of a healthy KETO diet supplemented with Canola oil, compared to a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380086/

Ketogenic Diet and Its Potential Role in Preventing Type 2 ... By examining 13 relevant studies, they found that the keto diet can effectively lower fasting blood sugar, reduce haemoglobin A1c, improve ...

8. mdpi.com mdpi.com/2072-6643/17/6/965

Ketogenic Diets for Body Weight Loss: A Comparison with ... A 2022 meta-analysis found that the very-low-carbohydrate ketogenic diet (VLCK), compared to diets routinely recommended for patients with type 2 diabetes, more ...

9. ctv.veeva.com ctv.veeva.com/study/metabolic-and-inflammatory-outcomes-of-the-ketogenic-diet-comparing-saturated-and-unsaturated-fat-so

Metabolic and Inflammatory Outcomes of the Ketogenic Diet ... The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO ...